Trial reportDrug design, development and therapy2025
Pharmacokinetics, Relative Bioavailability, and Safety of the SHR0302 Oral Solution and Tablets: A Single-Center, Randomized, Open-Label, Crossover (Two-Formulation, Two-Period) Phase I Trial in Healthy Chinese Volunteers.
Trial report in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Clinical Management of Antirheumatic Drug Exposure During Therapeutic Plasma Exchange.Clinical reviews in allergy & immunology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: This study investigates the pharmacokinetic characteristics and relative bioavailability of SHR0302 oral solution and tablets in healthy Chinese male volunteers. Patients and Methods: This single-center, randomized, open-label, crossover (two-formulation, two-period) phase I study enrolled 16 healthy male volunteers. Participants were randomized 1:1 to receive single dose 8mg of either the SHR0302 oral solution or the SHR0302 tablet. Blood samples were collected according to the protocol requirements, and SHR0302 plasma concentrations were analyzed using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). Pharmacokinetic parameters were calculated using a non-compartmental analysis in Phoenix WinNonlin (version 8.3). Data processing and analysis of pharmacokinetic characteristics and relative bioavailability were conducted using SAS software (version 9.4). Safety was assessed through treatment-emergent adverse events (TEAEs), vital signs, physical examinations, 12-lead electrocardiograms, and laboratory tests. Results: All 16 enrolled subjects completed the study. The geometric mean ratio (90% confidence interval) for C Conclusion: In healthy Chinese male volunteers, the bioavailability of the SHR0302 oral solution was comparable to that of the SHR0302 tablet. The drug was safe and well tolerated following a single dose.
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